Drug Marketing in China and Worldwide (July)

NMPA (National Medical Products Administration)

Listing Approval:

1. On July 4th, NMPA announced the approval of Huadong Medicine's Liraglutide Injection for a new indication, which is for the treatment of obesity or overweight patients. Liraglutide is a GLP-1 receptor agonist used for the treatment of type 2 diabetes in adults.On July 4th, NMPA announced the approval of Gloria Bio 's Sintilimab Injection for a new indication, which is for the treatment of cervical cancer. This is the first domestically approved PD-1 antibody drug for the treatment of cervical cancer.

2. On July 4th, NMPA announced the approval of Lvye's Acetate Goserelin Sustained-Release Microspheres (LY01005) for the treatment of prostate cancer. LY01005 is a long-acting sustained-release microsphere developed by Green Valley and is also intended for the treatment of breast cancer and endometriosis.

3. On July 4th, NMPA announced the approval of Sanofi's Nafamostat Hydrochloride Orally Disintegrating Tablets (TRK-820) for the improvement of pruritus in hemodialysis patients. This drug is a selective agonist of the κ-opioid receptor and was approved in Japan in 2017.

4. On July 4th, NMPA announced the approval of AbbVie's Upadacitinib Extended-Release Tablets for a new indication, which is for the treatment of moderate to severe active Crohn's disease in adult patients who have had an inadequate response, loss of response, or intolerance to one or more tumor necrosis factor (TNF) inhibitors.

5. On July 6th, NMPA announced the approval of Eli Lilly's Lasmiditan Tablets for the acute treatment of migraine attacks. Lasmiditan is a 5-HT1F receptor agonist and was approved by the FDA in October 2019 as the first 5-HT1F receptor agonist.

6. On July 12th, NMPA announced the approval of Daiichi Sankyo and AstraZeneca's Destura Pertuzumab Antibody-Drug Conjugate (ADC) for the treatment of adult patients with HER2-low expression (IHC1+ or IHC2+/ISH-) unresectable or metastatic breast cancer who have received at least one prior systemic therapy in the metastatic setting or within 6 months of completing adjuvant therapy. In hormone receptor-positive (HR+) breast cancer patients, prior endocrine therapy or ineligibility for endocrine therapy is also required.

7. On July 13th, NMPA announced the approval of GSK and ViiV Healthcare's Cabotegravir (Cabotegravir Injection and Cabotegravir Sodium Tablets) for the treatment of HIV. Cabotegravir is an integrase strand transfer inhibitor (INSTI) and is administered every two months.

8. On July 20th, NMPA announced the approval of Janssen's Bedaquiline Fumarate Tablets (trade name Staneer) for the treatment of multi-drug resistant tuberculosis in adolescents aged 12 to <18 years and weighing ≥30 kg as part of combination therapy. Bedaquiline is a novel anti-tuberculosis drug and was initially approved in China in 2016 for the treatment of multi-drug resistant pulmonary tuberculosis in adults.

9. On July 27th, NMPA announced the approval of Benemae's Benralizumab Injection for a new indication, which is for weight reduction. This is the first original research weight loss drug in China. Benralizumab is a humanized GLP-1 receptor agonist and was initially approved in December 2016 for the treatment of adults with type 2 diabetes to control blood sugar or for patients who cannot achieve adequate blood sugar control with metformin alone.

10. On July 27th, NMPA announced the approval of Zhongda Tianqing's Tucatinib Tablets (TQ-B211, trade name Saitu) for the treatment of HER2-positive early-stage breast cancer, metastatic breast cancer, and metastatic gastric cancer. Tucatinib becomes the third approved biosimilar of Tucatinib in China, following Hanqu developed by Fuhong Hanlin and Anrizhu developed by Borui Bio.

FDA

Listing Approval

1. On July 6th, the FDA's official website showed that Eisai's lecanemab (Leqembi) was fully approved by the FDA for the treatment of Alzheimer's disease. Lecanemab was originally jointly developed by Eisai and BioArctic, and it is β Specific binding of soluble oligomers of amyloid proteins. This drug is the first targeted drug β Amyloid protein, which has transitioned from accelerated approval to traditional approval for Alzheimer's disease therapy, is also the first time in 20 years that the FDA has fully approved an Alzheimer's disease drug.

2. On July 10th, the FDA official website showed that Novartis' siRNA drug, Inclisiran (trade name: Leqvio), targeting PCSK9, has been approved by the FDA to expand its indications as an adjuvant therapy for dietary and statin therapy to reduce low-density lipoprotein cholesterol (LDL-C) in primary hyperlipidemia patients with increased heart disease risk. In addition, the applicable population also includes patients with hypertension, diabetes and other complications but without cardiovascular events. At present, this therapy has been applied for and listed in China.

3. On July 20, the official website of FDA showed that Daiichi Sankyo's Quizartinib was approved for marketing for the treatment of newly diagnosed FLT3-ITD positive adult patients with acute myeloid leukemia (AML). This drug can be used in combination with the standard Cytarabine + Anthracycline induced remission treatment and Cytarabine consolidation treatment, as well as single drug for continuous treatment after consolidation. Quezatinib is an oral, selective second-generation FLT3 inhibitor.

EMA

Listing Approval

1. On July 20th, the EMA official website showed that the marketing application of Palovartene, a product of Yipu Sheng, for the treatment of progressive muscle ossification (FOP), was not approved. Parvastatin is an oral selective retinoic acid receptor developed by Clementia, a subsidiary of Roche γ (RAR γ） Agonists, in April 2019, Iproxen acquired Clementia for $1.31 billion, acquiring a global stake in Parvastatin. Previously, parovastatin was refused approval by the FDA.